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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K243930
Device Name Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
Applicant
Stryker Instruments
1941 Stryker Way
Kalamazoo,  MI  49002
Applicant Contact Louise Keane
Correspondent
Stryker Instruments
1941 Stryker Way
Kalamazoo,  MI  49002
Correspondent Contact Louise Keane
Classification Product Code
LFL  
Date Received12/20/2024
Decision Date 03/24/2025
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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